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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075559
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE;INJECTION Discontinued None No No
BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/20/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75559ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/13/2002 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/13/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/14/2001 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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